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Trial record 1 of 1 for:    NCT00407537
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Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors (CRUCIAL)

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ClinicalTrials.gov Identifier: NCT00407537
Recruitment Status : Completed
First Posted : December 5, 2006
Results First Posted : November 11, 2011
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 1, 2006
First Posted Date  ICMJE December 5, 2006
Results First Submitted Date  ICMJE October 6, 2010
Results First Posted Date  ICMJE November 11, 2011
Last Update Posted Date July 23, 2015
Study Start Date  ICMJE March 2007
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2011)
Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 [ Time Frame: Baseline, Month 12 ]
Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated at the end of study treatment (Month 12).
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2006)
The primary efficacy endpoint is the 10-year risk of developing total coronary heart disease using the Framingham Model at the end of 12 months.
Change History Complete list of historical versions of study NCT00407537 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2011)
  • Framingham 10-year Risk of Total CHD at Month 4 [ Time Frame: Baseline, Month 4 ]
    Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated after 4 months of treatment (Month 4).
  • European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12 [ Time Frame: Baseline, Month 12 ]
    European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 12 months of study treatment (Month 12).
  • European SCORE 10-year Risk of Fatal CVD at Month 4 [ Time Frame: Baseline, Month 4 ]
    European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 4 months of study treatment (Month 4).
  • Framingham 10-year Risk of Stroke at Month 12 [ Time Frame: Baseline, Month 12 ]
    Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific "calibration factor" for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).
  • Framingham 10-year Risk of Stroke at Month 4 [ Time Frame: Baseline, Month 4 ]
    Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific "calibration factor" for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).
  • Change From Baseline in Framingham 10-year Risk of Developing Total CHD [ Time Frame: Baseline, Month 4, Month 12 ]
    Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. Change from baseline calculated as mean at observation minus mean at Baseline.
  • Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD [ Time Frame: Baseline, Month 4, Month 12 ]
    European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. Change from baseline calculated as mean at observation minus mean at Baseline.
  • Mean Systolic and Diastolic Blood Pressure at Month 4 [ Time Frame: Month 4 ]
  • Mean Systolic and Diastolic Blood Pressure at Month 12 [ Time Frame: Month 12 ]
  • Change From Baseline in Systolic Blood Pressure (SBP) at Month 4 [ Time Frame: Baseline, Month 4 ]
  • Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4 [ Time Frame: Baseline, Month 4 ]
  • Change From Baseline in SBP at Month 12 [ Time Frame: Baseline, Month 12 ]
  • Change From Baseline in DBP at Month 12 [ Time Frame: Baseline, Month 12 ]
  • Mean Lipid Parameters at Month 4 [ Time Frame: Month 4 ]
    Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
  • Mean Lipid Parameters at Month 12 [ Time Frame: Month 12 ]
    Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
  • Change From Baseline in Lipid Parameters at Month 4 [ Time Frame: Baseline, Month 4 ]
    Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Change from baseline measured as mean at Month 4 minus mean at Baseline.
  • Change From Baseline in Lipid Parameters at Month 12 [ Time Frame: Baseline, Month 12 ]
    Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
  • Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months [ Time Frame: Month 4, Month 12 ]
    Goals set at <140/90 mmHg according to the seventh Joint National Committee (JNC) on prevention, detection, evaluation, and treatment of high blood pressure and <140/90 mm Hg or <130/80 mm Hg for diabetics ccording to the European Society of Cardiology (ESC) guidelines.
  • Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months [ Time Frame: Month 4, Month 12 ]
    Goal set at <100 mg/dL according to the United States (US) National Cholesterol Education Program Adult Treatment Panel 3 and at <80 mg/dL according to the European (EU) Society of Cardiology guidelines.
  • Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months [ Time Frame: Month 4, Month 12 ]
    Treatments indicative of prescribed medications other than study provided Caduet.
  • Number of Participants With Increase of Treatment Dosages After 4 Months. [ Time Frame: Month 4 ]
    Treatments indicative of prescribed medications other than study provided Caduet.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2006)
  • 10-year risk of developing total CHD using the Framingham Model at 4 months.
  • 10-year risk of developing fatal CHD using the European SCORE model at 4 and 12 months.
  • Blood pressure and lipid parameters at 4 and 12 months.
  • 10 year risk of developing stroke using the Framingham model for stroke at 4 and 12 months.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors
Official Title  ICMJE A Cluster Randomized Trial On Cardiovascular Risk Factor Management: Caduet Versus Usual Care In Subjects With Hypertension And Additional Cardiovascular Risk Factors In Clinical Practice
Brief Summary To investigate whether a Caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Hypercholesterolemia
Intervention  ICMJE Drug: Amlodipine besylate/atorvastatin calcium single pill combination
Open label amlodipine besylate/atorvastatin calcium single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion
Study Arms  ICMJE Experimental: Caduet
Open label caduet added to usual care regimen followed by investigators.
Intervention: Drug: Amlodipine besylate/atorvastatin calcium single pill combination
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2009)
1531
Original Enrollment  ICMJE
 (submitted: December 4, 2006)
1968
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hypertension with three additional risks factors (for example: smoking, type 2 diabetes, family history of early heart disease, history of stroke, age over 55 (men) and 65 (women)

Exclusion Criteria:

  • Subjects currently receiving a statin or stopped statin within 6 months prior to enrollment.
  • Subjects with a history of myocardial infarction and subjects with coronary bypass graft or intra-coronary interventions.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Costa Rica,   Croatia,   Czech Republic,   Dominican Republic,   Indonesia,   Jordan,   Korea, Republic of,   Kuwait,   Lebanon,   Malaysia,   Mexico,   Panama,   Philippines,   Russian Federation,   Saudi Arabia,   Taiwan,   Thailand,   Turkey,   United Arab Emirates,   Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00407537
Other Study ID Numbers  ICMJE A3841047
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP